The following data is part of a premarket notification filed by Popper & Sons, Inc. with the FDA for Hypodermic Needles, Single Lumen.
| Device ID | K911397 |
| 510k Number | K911397 |
| Device Name: | HYPODERMIC NEEDLES, SINGLE LUMEN |
| Classification | Biopsy Needle |
| Applicant | POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
| Contact | Joseph A Popper |
| Correspondent | Joseph A Popper POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-29 |
| Decision Date | 1991-05-20 |